This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | MODEL UV65 SERIES ANTERIOR CHAMBER LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1992-11-05 |
| Decision Date | 1994-10-17 |
| PMA | P880070 |
| Supplement | S005 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880070 | Original Filing | |
| S012 | 2007-04-12 | 30-day Notice |
| S011 | 2005-01-03 | Real-time Process |
| S010 | 2003-11-07 | Real-time Process |
| S009 | ||
| S008 | 1998-06-23 | Real-time Process |
| S007 | 1996-05-23 | Normal 180 Day Track |
| S006 | ||
| S005 | 1992-11-05 | Normal 180 Day Track |
| S004 | 1992-06-16 | Normal 180 Day Track |
| S003 | 1991-08-09 | Normal 180 Day Track |
| S002 | 1990-03-12 | Normal 180 Day Track |
| S001 | 1989-08-29 | Normal 180 Day Track |